Site Activation Manager- Spain

As a Site Activation Manager you will be responsible for the identification and activation of clinical sites and acting as the study functional lead for the Central Site Services team.  You will work directly with the Project Manager, Clients, Vendors, and other internal functional teams to ensure quality deliverables on-time and on-budget. Our mission is for our Catalyst staff to operate seamlessly with our customer teams using the Catalyst site centric model to enhance employee satisfaction while giving the sites and customers the reassurance that they have a strong and experienced team.

Position Accountabilities/Responsibilities:

• Participates in hand over meeting from feasibility team member.
• Coordinates site identification tasks; including but not limited to Site Feasibility Questionnaires (SFQs).
• Coordinates confidentiality agreement (CDA) negotiation and execution.
• Compiles site set-up process and develops site activation timeline for each site.
• Works with the study team to determine the IP Document Package requirements.
• Completes templated documents with study specific information.
• Develops IP Documents Release Package cover letter and gain approval as required.
• Coordinates and distributes the Essential Document Package (EDP) to the clinical sites.
• Reviews essential and non-essential documents from sites to ensure all required documents are accurate and complete.
• Develop Country/Site submission packages, per country requirements.
• Perform Competent Authority and Ethics submissions per country/site regulatory processes.
• Develop Submission Package to perform supplementary submissions, if applicable per country regulations.
• Coordinates the development of the site contract and budget templates.
• Develop Ancillary Budget and Contract templates, when needed (e.g. Laboratory, Pharmacy, Radiology) and perform facility negotiations and track the progress.
• Completes site contract and budget negotiations.
• Support with Import License and Export License applications, if applicable, per protocol and country requirements.
• Track the progress of site ID, Submissions, and Site Contracts negotiations activities in a Start-Up Reporting tracker/tool
• May support with country label reviews per regulations and country requirements
• Interfaces with Sponsor representatives and internal project team
• Compiles project-related activation packages (e.g. IP release, regulatory submission)
• Responsible for ensuring the filing and quality control of Site ID and activation documents during the startup period in the Trial Master File
• Confirms with Project Manager (or designee) that all study supplies, tools, etc. are available to ship to site in time for Site Initiation Visit (SIV).
• Inputs study timelines and other required fields into the tracking system, monitors and updates fields as study timelines or other information changes.
• Escalate study issues appropriately and in a timely manner.
• Assists with the development and maintenance of clinical study plans.
• Responsible for understanding the CSS budget on each project and the actions required to maintain it.
• Coordinates site ID and activation related meetings including agendas, decision logs and action item tracking.
• Collaborates and supports the project team with amendments to the protocol, ICF, site contract and site budget as needed.
• Assists with department activities and initiatives, as appropriate (e.g., process improvement, clinical system subject matter expert).
• Assists with mentoring or training junior staff.

Requirements/Responsibilities:  Education: University degree or equivalent education in a related field of study.

Experience:

At least 4 years in pharmaceutical research field (CRO, pharma, site, etc.) and 3 years of

applicable industry experience as part of start-up team or CRA role with start-up experience.

Required Skills:

•     Must have demonstrated expertise in relevant clinical and/or business operations activities; including but not limited to site regulatory document collection/review, ICF development/negotiation and/or site contract/budget negotiation.

•     Strong ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results.

•     Strong working knowledge of ICH/GCP guidelines and local country ethics and competent authority regulations (requisite knowledge may be obtained during performance of job duties through appropriate training (both on site and/or e-training programs).

•     Exceptional written and verbal communication skills.

•     Strong ability to work well under pressure and coordinate multiple tasks that affect critical timelines.

•     Strong ability to multitask and work in a fast-paced dynamic environment required.

Working Conditions:  ​Sedentary work that primarily involves sitting/standing.​